Defence Online

Type of document: Contract Notice
Country: United Kingdom
Publication Ref: (2023/S 000-009030/EN)
Nature of contract:
Procedure: Not applicable

Contract notice

Section I: Contracting authority
I.1) Name addresses and contact point(s):
Ministry of Defence, Defence Science and Technology Laboratory
Porton Down
Salisbury, Wiltshire
Postal code: SP4 0JQ
United Kingdom
For the attention of: ADP Procurement
Email: ADPProcurement@dstl.gov.uk
Address of the buyer profile: www.contracts.mod.uk
Electronic access to information: www.contracts.mod.uk
Electronic submission of tenders and requests to participate: www.contracts.mod.uk
Further information can be obtained from: The above mentioned contact point(s)
Specifications and additional documents (including documents for competitive dialogue and a dynamic purchasing system) can be obtained from: The above mentioned contact point(s)
Tenders or requests to participate must be sent to: The above mentioned contact point(s)
I.2) Type of the contracting authority:
Ministry or any other national or federal authority, including their regional or local sub-divisions
I.3) Main activity:
Defence
I.4) Contract award on behalf of other contracting authorities/entities:
The contracting authority is purchasing on behalf of other contracting authorities: No
Section II: Object of the contract:
II.1) Description:
II.1.1) Title attributed to the contract by the contracting authority/entity: The Development, Validation and Supply of Physostigmine Free Base
II.1.2) Type of contract and location of works, place of delivery or of performance:
Supplies
Type of supplies contract: Purchase
Nuts code:
II.1.3) Information about a public contract, a framework agreement or a dynamic purchasing system (DPS)
II.1.4) Information on framework agreement
II.1.5) Short description of the specific contract:
The Ministry of Defence (MoD) is inviting expressions of interest for a requirement for the provision of Physostigmine Free Base(also known as eserine; chemical name 1,2,3,3aβ,8,8aβ-hexahydro-1,3a,8-trimethylpyrrolo[2,3-b] indol-5-yl-methylcarbamate; chemical formula C15H21N3O2; molecular weight 275,36 g/mol). as part of an ongoing product development and anticipated commercialisation.
The initial Physostigmine supplied must be suitable for use in a pivotal Phase I clinical setting and the manufacturing process will produce material which does not add additional non-clinical activities to the overall programme, best endeavours should be taken to remove processing impurities.
The Supplier is to develop, scale-up and validate the manufacturing method for Physostigmine Free Base as an Active Pharmaceutical Ingredient (API) for use in a MoD final medicinal product currently under development.
The API must be developed and manufactured according to Good Manufacturing Practice (GMP) and must conform to European Transmissible Spongiform Encephalopathies (TSE) requirements, developed such that Intellectual property (IP) is vested in the Authority.
The Authority intends to seek a Marketing Authorisation for the final medicinal product from the Medicines and Healthcare products Regulatory Agency (MHRA) and Physostigmine will be required as an active ingredient for a future registered medicinal product.
The Supplier is required to provide information necessary for the Authority to complete the Chemistry, Manufacturing and Control (CMC) documentation to support a Clinical Trial Application (CTA) and Marketing Authorisation Application for the final medicinal product and make this documentation available to the MA applicant in an appropriate format for inclusion within CTD Module 3.
The Authority anticipates a Limited Quality by Design (QBD) approach to the manufacturing process as defined by the International Conference on Harmonisation (ICH).
All procurement documents are accessible via www.contracts.mod.uk

II.1.6) Common procurement vocabulary (CPV): 33661700, 33660000, 33690000, 73300000,
II.1.7) Information about Government Procurement Agreement (GPA):
The contract is covered by the Government Procurement Agreement (GPA):
II.1.8) Lots:
The contract is divided into lots: No
II.1.9) Information about variants:
Variants will be accepted: NO
II.2) Quantity or scope of the contract:
II.2.1) Total quantity or scope:
The Contract has an expected duration of 10 years (120 months), plus 5 option years (60 months). Option years may be taken up consecutively or concurrently (to be determined).
Estimated value excluding VAT:
Range: between 3000000 and 10000000 GBP
II.2.2) Information about options:
Options: yes
Up to 5 optional years in addition to the initial 10 year duration. These option years may be taken up individually for each separate option year or in totality for the whole five year period.
II.2.3) Information about renewals:
This contract is subject to renewal: yes
Number of possible renewals:
II.3) Duration of the contract or time limit for completion
Duration in months: 180 (from the award of the contract)

Section III: Legal, economic, financial and technical information
III.1) Conditions relating to the contract
III.1.1) Deposits and guarantees required:
To be specified in the Invitation to Negotiate
III.1.2) Main financing conditions and payment arrangements and/or reference to the relevant provisions governing them:
III.1.3) Legal form to be taken by the group of economic operators to whom the contract is to be awarded:
To be specified in the Invitation to Negotiate
III.1.4) Other particular conditions
The performance of the contract is subject to particular conditions: yes
Description of particular conditions: To be specified in the Invitation to Negotiate
III.2) Conditions for participation
III.2.1) Personal situation of economic operators, including requirements relating to enrolment on professional or trade registers

Suppliers Instructions How to Express Interest in this Tender:
1. Register your company on the eSourcing portal (this is only required once)
– Browse to the eSourcing Portal
– Click the “Click here to register” link
– Accept the terms and conditions and click “continue”
– Enter your correct business and user details
– Note the username you chose and click “Save” when complete
– You will shortly receive an email with your unique password (please keep this secure)
2. Express an Interest in the tender
– Login to the portal with the username/password
– Click the “PQQs Open to All Suppliers” link. (These are Pre-Qualification Questionnaires open to any registered supplier)
– Click on the relevant PQQ to access the content.
– Click the “Express Interest” button in the “Actions” box on the left-hand side of the page.
– This will move the PQQ into your “My PQQs” page. (This is a secure area reserved for your projects only)
– Click on the PQQ code, you can now access any attachments by clicking the “Settings and Buyer Attachments” in the “Actions” box
3. Responding to the tender
– You can now choose to “Reply” or “Reject” (please give a reason if rejecting)
– You can now use the ‘Messages’ function to communicate with the buyer and seek any clarification
– Note the deadline for completion, then follow the onscreen instructions to complete the PQQ
– There may be a mixture of online & offline actions for you to perform (there is detailed online help available)
If you require any further assistance please consult the online help, or contact the eTendering help desk.

III.2.2) Economic and financial ability
See PQQ
Minimum level(s) of standards possibly required:
See PQQ

III.2.3) Technical capacity
Information and formalities necessary for evaluating if the requirements are met: See PQQ
Minimum level(s) of standards possibly required:
III.2.4) Information about reserved contracts
III.3) Conditions specific to services contracts
III.3.1) Information about a particular profession
Execution of the service is reserved to a particular profession:
III.3.2) Staff responsible for the execution of the service
Legal persons should indicate the names and professional qualifications of the staff responsible for the execution of the service:
Section IV: Procedure
IV.1) Type of procedure
IV.1.1) Type of procedure
Negotiated
IV.1.2) Limitations on the number of operators who will be invited to tender or to participate
Envisaged minimum number: 3 and maximum number 6
IV.1.3) Reduction of the number of operators during the negotiation or dialogue
IV.2) Award criteria
The most economically advantageous tender in terms of the criteria stated in the specifications, in the invitation to tender or to negotiate or in the descriptive document
IV.2.2) Information about electronic auction

IV.3) Administrative information
IV.3.1) File reference number attributed by the contracting authority/entity
IV.3.2) Previous publication(s) concerning the same contract

IV.3.3) Conditions for obtaining specifications and additional documents or descriptive document
Payable documents: Yes
IV.3.4) Time limit for receipt of tenders or requests to participate
28.4.2023 – 17:00
IV.3.5) Date of dispatch of invitations to tender or to participate to selected candidates
IV.3.6) Language(s) in which tenders or requests to participate may be drawn up
EN
IV.3.7) Minimum time frame during which the tenderer must maintain the tender
In days:
IV.3.8) Conditions for opening of tenders

Section VI: Complementary information
VI.1) Information about recurrence
VI.2) Information about European Union funds
The contract is related to a project and/or programme financed by European Union funds: No
VI.3) Additional information
The Contracting Authority intends to use an e-Tendering system in this procurement exercise, please visit www.contracts.mod.uk for full details and to register your interest in this procurement.
The Cyber Risk Profile for this requirement identified by the Cyber Risk Assessment is Very Low (Reference – RAR-800645056).
VI.4) Procedures for appeal
VI.4.1) Body responsible for appeal procedures:
Defence Science and Technology Laboratory
Porton Down
Salisbury
Postal code: SP4 0JQ
United Kingdom
Body responsible for mediation procedures:
Defence Science and Technology Laboratory
Porton Down
Salisbury
Postal code: SP4 0JQ
VI.5) Date of dispatch of this notice:
28.3.2023